Stylet For Catheter, Gastro-Urology
FDA adverse event reports and recall history for stylet for catheter, gastro-urology (product code EZB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,445
- Deaths
- 24
- Injuries
- 480
- Malfunctions
- 1,936
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2020-04-01Open, ClassifiedComponent change control
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M0066703050 single unit
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-01Open, ClassifiedComponent change control
Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-01Open, ClassifiedComponent change control
Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-01Open, ClassifiedComponent change control
Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M0066703100 single unit
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-01Open, ClassifiedComponent change control
Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-01Open, ClassifiedComponent change control
Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-01Open, ClassifiedComponent change control
Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-01Open, ClassifiedComponent change control
Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-01Open, ClassifiedComponent change control
Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
- 2020-04-01Open, ClassifiedComponent change control
Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device
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